NIPH Clinical Trials Search

UMIN ID: C000000308

Registered date:19/01/2006

Phase II study of gemcitabine alone in locally advanced pancreatic cancer: Japan Clinical Oncology Group Study (JCOG 0506)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedpancreatic neoplasm
Date of first enrollment2006/01/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Patients receive 30-minute infusion of gemcitabine (1000 mg/m2/day, days 1, 8, and 15) every 4 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.


Primary Outcome1-year overall survival
Secondary Outcomeclinical benefit response (CBR), CA19-9 response, adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaPatients are excluded if they meet the following criteria: They have obvious ascetic or pleural effusion, lung fibrosis or pneumonitis, uncontrolled diabetes mellitus in spite of using more than 40 unit insulin, Classification of New York Heart Association (NYHA) of III or IV, myocardial infarction within 6 months before this trial, synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, or severe mental disease.

Related Information


public contact
Name Hiroshi Ishiii, MD, PhD
Address 63-10-6,Ariake,Koto-ku,Tokyo 135-8550,Japan Japan
Affiliation JCOG0506 Coordinating Office Medical Oncology Division, National Cancer Institute Hospital
scientific contact
Name Junzi Furuse, MD, PhD
Address 6-20-2,Shinkawa,Mitaka,Tokyo 181-8611,Japan Japan
Affiliation Kyorin University School of Medicine Medical Oncology Division